Kinesiotape and Dysphagia
Primary Purpose
Dysphagia, Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Kinesiotape, Swallowing, Cerebral Palsy, Dysphagia
Eligibility Criteria
Inclusion Criteria:
- Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.
Exclusion Criteria:
- Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.
Sites / Locations
- Gaziantep University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Kinesiotape Group
Sham Kinesiotape Group
Arm Description
In active group, KT was applied with stretching to the suprahyoid muscles with right method.
In sham group, KT was applied without stretching to the suprahyoid region and not including the origins of mylohyoid and digastric muscles
Outcomes
Primary Outcome Measures
Functional oral intake scale
The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels.
Secondary Outcome Measures
Family satisfaction level
Children's primary caregivers were asked to evaluate the change in swallowing of children at 6th and 18th weeks with 5-point Likert scale. Accordingly, "so much better" to "so much worse" were scored between 1 and 5.
Full Information
NCT ID
NCT04750174
First Posted
February 6, 2021
Last Updated
February 6, 2021
Sponsor
University of Gaziantep
1. Study Identification
Unique Protocol Identification Number
NCT04750174
Brief Title
Kinesiotape and Dysphagia
Official Title
Effectiveness of Kinesiotape on Children With Cerebral Palsy and Oropharyngeal Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP.
Detailed Description
There is a few studies for the effectiveness of KT application in the treatment of dysphagia and its effectiveness is controversial. These small-scale studies conducted to improve control of drooling in the oral phase of swallowing in CP. However, there are no studies that have evaluated swallowing as a whole. Moreover, there is a need to carry out studies evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and duration of effectivenes for a period longer than 3 months. This study is designed to answer the following research questions: "Is KT application effective in the treatment of dysphagia in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Cerebral Palsy
Keywords
Kinesiotape, Swallowing, Cerebral Palsy, Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
Masking
ParticipantInvestigator
Masking Description
A short practical training was performed before the study. The study was performed by a group of independent specialists blinded to treatment allocation.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesiotape Group
Arm Type
Active Comparator
Arm Description
In active group, KT was applied with stretching to the suprahyoid muscles with right method.
Arm Title
Sham Kinesiotape Group
Arm Type
Sham Comparator
Arm Description
In sham group, KT was applied without stretching to the suprahyoid region and not including the origins of mylohyoid and digastric muscles
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .
Primary Outcome Measure Information:
Title
Functional oral intake scale
Description
The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Family satisfaction level
Description
Children's primary caregivers were asked to evaluate the change in swallowing of children at 6th and 18th weeks with 5-point Likert scale. Accordingly, "so much better" to "so much worse" were scored between 1 and 5.
Time Frame
18th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.
Exclusion Criteria:
Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazlum Serdar Akaltun, M.D.
Organizational Affiliation
University of Gaziantep
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziantep University
City
Gaziantep
ZIP/Postal Code
27300
Country
Turkey
12. IPD Sharing Statement
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Kinesiotape and Dysphagia
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